Senior Medical Device Specialist

2 days ago


Kurnool, Andhra Pradesh, India beBeeMedical Full time ₹ 20,00,000 - ₹ 25,00,000

Job Title: Senior Medical Device Specialist

We are seeking a highly experienced Senior Medical Device Specialist to lead our medical device assessment and auditing initiatives. This role involves ensuring compliance with regulatory requirements across various jurisdictions.

Key Responsibilities:

  • Evaluate medical devices for conformity to ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
  • Assess the application of Risk Management EN ISO 14971 in medical device development.
  • Collaborate with cross-functional teams to ensure effective quality management.

Requirements:

  • 10+ years of experience in medical devices or related fields, including research and development, manufacturing, and regulatory affairs.
  • 5+ years of experience in quality management is essential.

Preferred Skills:

  • Strong knowledge of sterilization processes and non-active devices.
  • Excellent communication and teamwork skills.

This individual will be responsible for implementing and maintaining rigorous quality standards. A self-motivated professional with a passion for medical device quality will excel in this role.



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